Method and apparatus for resecting and replacing an aortic valve

ABSTRACT

A method and apparatus for delivering a device to a given location within a heart, the method and apparatus being adapted for: passing a first catheter through the left atrium of the heart, through the mitral valve and into the left ventricle, and passing a second catheter through the aorta toward the heart, one or the other of the first catheter and the second catheter, with the device attached thereto, forming a device-carrying assembly for engagement with the remaining catheter; causing the device-carrying assembly and the remaining catheter to engage one another so as to form a connection therebetween; and retracting one of the device-carrying assembly and the remaining catheter in a direction opposite to the other of the device-carrying assembly and the remaining catheter so as to position the device relative to the given location within the heart.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation application of U.S. patentapplication Ser. No. 10/894,677, filed Jul. 19, 2004 now U.S. Pat. No.7,544,206, now allowed, which is a continuation-in-part of Ser. No.10/414,741, filed Apr. 16, 2003, now U.S. Pat. No. 7,201,761, issuedApr. 10, 2007, and is a continuation-in-part of Ser. No. 09/896,259,filed on Jun. 29, 2001, now U.S. Pat. No. 6,769,434, issued Aug. 3,2004, and claims priority to U.S. Provisional Application No.60/488,548, filed Jul. 18, 2003, and titled “Method and Apparatus forResecting and Replacing an Aortic Valve”, the entire contents of whichare incorporated herein by reference in their entirety.

FIELD OF THE INVENTION

This invention relates to apparatus and methods for performing cardiacsurgery in general, and more particularly to apparatus and methods forperforming cardiac surgery while the heart is beating.

BACKGROUND OF THE INVENTION

Of all valvular heart lesions, aortic stenosis carries the worstprognosis. Within one year of diagnosis, approximately half of allpatients with critical aortic stenosis have died, and by three years,this figure rises to approximately 80%. Currently, the most prominentand effective treatment for patients with aortic stenosis is aorticvalve replacement via open heart surgery. Unfortunately, this procedureis a substantial and invasive undertaking for the patient.

While there have been significant advances in heart valve technologyover the past 30 years, there has been little progress in thedevelopment of safer and less invasive valve delivery systems. Aorticvalve replacement currently requires a sternotomy or thoracotomy, use ofcardiopulmonary bypass to arrest the heart and lungs, and a largeincision on the aorta. The native valve is resected through thisincision and then a prosthetic valve is sutured to the inner surface ofthe aorta with a multitude of sutures passing only partly into the wallof the aorta. Given the current invasiveness of this procedure and therequirement to utilize cardiopulmonary bypass, aortic valve replacementsurgery is associated with a high risk of morbidity and mortality. Thisis especially true in elderly patients, and in those patients whorequire concomitant coronary artery bypass grafting. Even when a goodsurgical result is achieved, virtually all patients requireapproximately 6 weeks to several months to fully recover from theprocedure. In order to decrease these associated risks of aortic valvesurgery, many have pursued novel approaches and technologies.

Less invasive approaches to aortic valve surgery have generally followedtwo paths.

In the 1980's, there was a flurry of interest in percutaneous balloonvalvotomy. In this procedure, a cardiologist introduced a catheterthrough the femoral artery to dilate the patient's aortic valve, therebyrelieving the stenosis. Using the technology available at that time,success was limited: the valve area was increased only minimally, andnearly all patients had restenosis within one year.

More recently, surgeons have approached the aortic valve via smallerchest wall incisions. However, these approaches still requirecardiopulmonary bypass and cardiac arrest, which themselves entailsignificant morbidity and a prolonged post-operative recovery.

The ideal minimally invasive approach to the treatment of aortic valvedisease requires aortic valve replacement without cardiopulmonary bypassand without cardiac arrest. Such an approach would greatly reducepatient morbidity and mortality and hasten recovery. Unfortunately,although there has been great progress in the treatment of coronaryartery disease without cardiopulmonary bypass (e.g., angioplasty, withor without stenting, and “off-pump” coronary artery bypass grafting),similar advances have not yet been realized in heart valve surgery. Withan aging population and improved access to advanced diagnostic testing,the incidence and accurate diagnosis of aortic stenosis will continue toincrease. The development of a system for “off-pump” aortic valvereplacement would be of significant benefit to this increasing patientpopulation.

There are three important challenges to replacing a diseased aorticvalve without cardiopulmonary bypass.

The first challenge is to remove the diseased valve without causingstroke or other ischemic events that might result from the liberation ofparticulate material while removing the diseased valve.

The second challenge is to prevent cardiac failure during removal of thediseased valve. In this respect it must be appreciated that the aorticvalve continues to serve a critical function even when it is diseased.However, as the diseased valve is removed, it becomes acutely andseverely incompetent, causing the patient to develop heart failure whichresults in death unless the function of the valve is taken over byanother means.

The third challenge is placing a prosthetic valve into the vascularsystem and affixing it to the wall of the aorta. More particularly,during cardiac rhythm, the aortic and arterial pressures aresubstantially greater than atmospheric pressure. Therefore, any sizableincision made to the aorta in order to insert a standard valveprosthesis into the arterial system creates the potential foruncontrollable bleeding from the incision site. Furthermore, even ifbleeding is successfully controlled, pressures within the aorta mayresult in weakening of the aorta caused by aortic wall dissection. Inaddition, large incisions on the aorta also increase the potential forliberating plaque from the aortic wall that can lead to emboliccomplications.

For these reasons, prior art valve prostheses potentially suitable foroff-pump implantation have relied upon relatively flimsy expandablestructures to support and secure the valve within the aorta. Moreparticularly, these prosthetic valves are constructed so that they canbe compressed to a relatively small dimension suitable for insertioninto the arterial system, advanced to the site of the aortic valve, andthen expanded against the aortic wall. Unfortunately, however, none ofthese relatively flimsy valve prostheses have proven adequate to endurethe repetitive stresses undergone by the aortic valve over the ten totwenty years typically required.

In addition to the foregoing, the precise placement of such expandableprosthetic valves in the correct sub-coronary position can be extremelychallenging, particularly in view of the high pressure, pulsatile bloodflow passing through the aorta. Furthermore, expandable prostheticvalves would typically be positioned from a remote artery, which wouldreduce the ability to precisely control the placement and positioning ofthe device and therefore would increases the risk of obstructing thecoronary arteries. The expandable prosthetic valves are held on the endsof elongate, flexible catheters that are threaded into the aorta, aroundthe aortic arch and then expanded. The pulsatile flow during cardiacrhythm induces a to-and-fro motion of the valve prosthesis relative tothe aorta that makes the timing of valve expansion critical for properplacement of the expandable prosthetic valve and hence the survival ofthe patient.

Finally, many of the challenges discussed in the foregoing sectionpertaining to aortic valve replacement are also relevant to otherprocedures in the aortic root such as aortic valve resection; aorticvalve decalcification, stent grafting for aortic dissections, etc.

SUMMARY OF THE INVENTION

It is, therefore, one object of the present invention to enable thepassage of a device from the left atrium, through the left ventricle,and into the arterial system.

Further, another object of the present invention is to enable theimplantation of a device in the arterial system without cardiopulmonarybypass.

Further, another object of the present invention is to enable theimplantation of a prosthetic valve in the arterial system withoutcardiopulmonary bypass.

Another object of the present invention is to allow the insertion ofsuch a valve while minimizing the risks to the patient posed by largearterial incisions.

And another object of the present invention is to simplify the preciseplacement of such a valve.

Further, another object of the present invention is to enable theimplantation of a device other than a valve, such as but not limited toa valve resection tool, a decalcifying tool, an aortic valve repairtool, or a stented aortic graft, in the arterial system withoutcardiopulmonary bypass.

Another object of the present invention is to allow the insertion of adevice other than a valve, such as but not limited to a valve resectiontool, a decalcifying tool, an aortic valve repair tool, or a stentedaortic graft, while minimizing the risks to the patient posed by largearterial incisions.

And another object of the present invention is to simplify the preciseplacement of a device other than a valve, such as but not limited to avalve resection tool, a decalcifying tool, an aortic valve repair tool,or a stented aortic graft.

These and other objects of the invention are addressed by the presentinvention which, in one form of the invention, comprises a method fordelivering a device to a given location within a heart, the methodcomprising:

passing a first catheter through the left atrium of the heart, throughthe mitral valve and into the left ventricle, and passing a secondcatheter through the aorta toward the heart, one or the other of thefirst catheter and the second catheter with the device attached theretoforming a device-carrying assembly for engagement with the remainingcatheter;

causing the device-carrying assembly and the remaining catheter toengage one another so as to form a connection therebetween;

retracting one of the device-carrying assembly and the remainingcatheter in a direction opposite to the other of the device-carryingassembly and the remaining catheter so as to position the devicerelative to the given location within the heart.

In another form of the invention, there is provided an apparatus fordelivering a device to a given location within a heart, the apparatuscomprising:

a first catheter and a second catheter, the first catheter having aproximal end and a distal end, the distal end of the first catheterconfigured to pass through the left atrium of the heart, through themitral valve into the left ventricle, the second catheter configured topass through the aorta and the aortic valve, and at least one of thefirst catheter and the second catheter carrying the device; and

connection means for selectively connecting the distal end of the firstcatheter and distal end of the second catheter to one another;

wherein the first catheter and the second catheter are connectedtogether such that the device is positioned relative to the givenlocation within the heart by selectively retracting one of the firstcatheter and the second catheter so as to move the connected cathetersthrough the heart.

In another form of the invention, there is provided a method fordelivering a device to a given location within a heart, the methodcomprising:

advancing a first catheter through the left atrium of the heart, throughthe mitral valve and into the left ventricle;

advancing a second catheter through the aorta toward the heart,advancing the second catheter through the aortic valve;

connecting the first catheter and the second catheter together; and

retracting one of the first catheter and the second catheter in adirection opposite to one another so as to position the device relativeto the given location within the heart.

In another form of the invention, there is provided a method forpositioning a device at a given location within a heart, the methodcomprising:

inserting a distal end of a first catheter into a left atrium of theheart;

inserting a distal end of a second catheter into an aorta toward theheart;

advancing at least one of the distal end of the first catheter and thedistal end of the second catheter through the heart to position thedistal end of the first catheter and the distal end of the secondcatheter adjacent to one another;

attaching the first catheter and the second catheter to one another;

retracting one of the first catheter and the second catheter, with thedevice in attachment to one of the first catheter and the secondcatheter, so as to position the device adjacent to the given locationwithin the heart.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like elements and further wherein:

FIG. 1 is a schematic side view showing the introduction of a valveprosthesis and prosthesis holding apparatus into the left atrium of theheart, through an atriotomy, using a first manipulation instrument;

FIG. 2 is a schematic side view showing passage of the apparatus of FIG.1 from the left atrium, through the mitral valve, and into the leftventricle;

FIG. 3 is a schematic side view showing the introduction of a secondmanipulation instrument into the left ventricle through an arteriotomyinto the arterial system;

FIG. 4 is a schematic side view showing the second manipulationinstrument being attached to the prosthesis holding apparatus while thefirst manipulation instrument remains secured to the prosthesis holdingapparatus;

FIG. 5 is a schematic side view similar to that of FIG. 4, exceptshowing the first manipulation instrument being removed from thesurgical site while the second manipulation instrument remains securedto the prosthesis holding apparatus;

FIG. 6 is a schematic side view showing the second manipulationinstrument positioning the prosthetic valve within the aorta prior tofixation;

FIG. 7 is a schematic side view showing the prosthetic valve secured tothe tissues of the aorta following removal of the second manipulationinstrument and prosthesis holding apparatus;

FIGS. 8, 9 and 10 are enlarged schematic views showing a preferredconstruction for the valve holding apparatus, and for the attachment to,and detachment from, the prosthetic valve;

FIG. 11 is a schematic view showing a guide for guiding the secondmanipulation instrument relative to the first manipulation instrumentsuch that the second manipulation instrument will be aimed directly atthe second manipulation mount when the first manipulation mount issecured to the first manipulation instrument;

FIG. 12 is a perspective view of a preferred embodiment of the presentinvention for a punch configured for a left ventricle approach to adiseased valve;

FIGS. 13-17 are schematic views of preferred embodiments of the presentinvention for a punch configured for an aortic approach to a diseasedvalve;

FIGS. 18-22 are schematic views of preferred embodiments of the presentinvention for resection of a heart valve using a power shaver incombination with a power shaver guide;

FIGS. 23-32 are schematic views of an expandable resector views of anexpandable resector with three arms, in which one of the arms carries acutting device;

FIGS. 33-37 are schematic views of a spiked resector for holdingportions of the valve prior to closing the cutting portions together;

FIGS. 38-49 are schematic views of a preferred embodiment of the presentinvention including an expandable blade resector delivered through acatheter;

FIGS. 50-57 are schematic views of a preferred embodiment of the presentinvention including an expandable cylinder resector delivered through acatheter;

FIGS. 58-60 are schematic views of a preferred embodiment of the presentinvention including a power auger cutter for cutting and removingportions of a heart valve;

FIGS. 61, 62, 62A-A, 63 & 63A-A are schematic views of a preferredembodiment of the present invention including an offset cutter;

FIGS. 64-70 are schematic views of a preferred embodiment of the presentinvention including a trisector having three cutting blades;

FIGS. 71-76 are schematic views of a preferred embodiment of theinvention including a valve entrapment cutter;

FIGS. 77-79 are schematic views of a preferred embodiment of theinvention including a gripper cutter having a pair of graspers and acutting element;

FIGS. 80-90 are schematic views of a preferred embodiment of the presentinvention including a valve cutter and resector for use with a leftventricle approach;

FIG. 91 is a schematic view of a resection tool having several differenttypes of protective guides;

FIGS. 92-101 are schematic views of a preferred embodiment of thepresent invention including a valve cutter and resector for use with aleft ventricle approach, the valve cutter and resector having anumbrella covered by filter material; and

FIGS. 102-105 are schematic views of a preferred embodiment of thepresent invention including a debridement tool controlled by adebridement catheter, which is introduced in an antegrade approach, anda transvalvular catheter, which is introduced in a retrograde approach,to engage one another in a mechanical or magnetic coupling. FIG. 1 is aperspective view of one embodiment of a delivery system of theinvention;

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention can be used to deliver or implant a variety ofprostheses into the arterial system or left side of the heart. Theprosthesis used in the preferred embodiment is an aortic valveprosthesis. Alternatively, the prosthesis may comprise, but is notlimited to, a cylindrical arterial stent, an arterial prosthesis orgraft, a ventricular assist device, a device for the treatment of heartfailure such as an intraventricular counterpulsation balloon, chordaetendinae prostheses, arterial filters suitable for acute or chronicfiltration of emboli from the blood stream, arterial occlusion devicesand the like.

For clarity of illustration, the present invention will hereinafter bediscussed in the context of implanting an aortic valve prosthesis.

It should also be appreciated that the present invention may bepracticed either “on-pump” or “off-pump”. In other words, the presentinvention may be performed either with or without the support ofcardiopulmonary bypass. The present invention also may be performedeither with or without cardiac arrest.

Looking now at FIG. 1, there is shown an exemplary embodiment of thepresent invention. A prothesis holding apparatus 100 is secured to aprosthetic valve 200 so as to form a temporary prosthetic assembly 300.A first manipulation instrument 400 is secured to a first manipulationmount 105 formed on prosthesis holding apparatus 100, whereby temporaryprosthetic assembly 300 may be moved about by first manipulationinstrument 400. Temporary prosthetic assembly 300 has been positioned inleft atrium 5 by passing first manipulation instrument 400 throughatriotomy 10. Alternatively, the temporary prosthetic assembly 300 couldbe passed into the left atrium 5, using first manipulation instrument400, through any of the pulmonary veins 15 (not shown). And in anotherform of the invention, temporary prosthesis assembly 300 could be passedinto the left atrium by first passing the assembly into the right atriumvia an atriotomy, and then into the left atrium is through an incisionmade in the interatrial septum.

Prosthetic valve 200 is preferably a conventional mechanical aorticvalve of the sort well known in the art, although other forms of valveprostheses may also be used.

In one preferred form of the invention, first manipulation instrument400 functions by virtue of the relative motion of an outer cannula 405relative to an inner grasper 410. More particularly, inner grasper 410has an elastically deformable distal gripper 415 which is open when thegripper is outside of outer cannula 405. However, when deformablegripper 415 is pulled at least partially into or against outer cannula405, gripper 415 is elastically deformed into a closed position, wherebyit may grip an object, e.g., first manipulation mount 105 formed onprosthesis holding apparatus 100. First manipulation instrument 400 isshown in FIG. 1 in its closed position, wherein deformable gripper 415is closed about first manipulation mount 105, such that prosthesisholding apparatus 100, and hence the entire temporary prostheticassembly 300, is held secured to the distal end of first manipulationinstrument 400.

The specific embodiment of first manipulation instrument 400 shown inFIG. 1 is presented as an illustrative example only, and is not intendedto limit the scope of the present invention. Many other arrangements maybe used for releasably gripping first manipulation mount 105 formed onprosthesis holding apparatus 100. Furthermore, first manipulation mount105 may itself have many potential shapes and properties to enablereleasable attachment to first manipulation instrument 400. Otherpossible configurations for releasably securing first manipulation mount105 to first manipulation instrument 400 include, but are not limitedto, opposing magnet poles in the mount and instrument, adhesives, apress fit between mount and instrument, threaded couplings, sutureloops, a balloon or balloons expanded within a mating cavity,collapsible barbs, etc. For the purposes of the present invention, theimportant point is that some arrangement be provided for releasablysecuring the prosthesis holding apparatus (and hence the prostheticvalve) to a manipulation instrument.

Still looking now at FIG. 1, first manipulation instrument 400 is shownas having a long axis that extends outside of the heart, with firstmanipulation instrument 400 being straight along that axis. However, itshould also be appreciated that first manipulation instrument 400 may,alternatively, be formed with a curve at one or more location along thislength. Furthermore, first manipulation instrument 400 may beconstructed so as to allow articulation at the distal end, the proximalend, or both, or at any point therebetween. In addition, firstmanipulation instrument 400 may be formed either entirely rigid orsubstantially flexible, along all or part of its length.

First manipulation instrument 400 is also shown as having a relativelysmall dimension perpendicular to its long axis. This configurationallows atriotomy 10 to be reduced in size after the passage of temporaryprosthetic assembly 300 into left atrium 5. This perpendicular dimensionmay be constant or varied along the long axis of first manipulationinstrument 400.

The specific embodiment of the prosthesis holding apparatus 100 shown inFIG. 1 is presented as an illustrative example only, and is not intendedto limit the scope of the present invention. Many other arrangements maybe used for releasably gripping prosthetic valve 200 and for providingfirst manipulation mount 105, as well as providing a second manipulationmount 110 that will be discussed below. In FIG. 1, first manipulationmount 105 and second manipulation mount 110 are shown as sphericaladditions to struts 115 extending away from prosthetic valve 200. Thesespheres are intended to fit, respectively, within the deformable gripper415 of first installation instrument 400 and the deformable gripper 515of a second installation instrument 500 (discussed below). Firstmanipulation mount 105 and/or second manipulation mount 110 could,alternatively, be indentations within a portion of male or femalethreaded extensions from, magnetized surfaces of, slots or holes in orthrough, prosthesis holding apparatus 100, etc. Furthermore, firstmanipulation mount 105 and/or second manipulation mount 110 could beportions of the struts 115 extending away from prosthetic valve 200,where those portions may be either reduced or enlarged in dimensionrelative to neighboring portions of the struts. Many other constructionsmay also be used to form first manipulation mount 105 and secondmanipulation mount 110. For the purposes of the present invention, theimportant point is that some arrangement be provided for releasablysecuring the prosthesis holding apparatus (and hence the prostheticvalve) to manipulation instruments.

Still looking now at FIG. 1, it will be appreciated that the nativeaortic valve has been removed. Removal of the native aortic valve is nota necessary element of the present invention, but may be incorporatedinto the preferred method. Removal of the native aortic valve may beaccomplished either before or after passage of the temporary prostheticassembly 300 into left atrium 5.

When the methods and devices of the present invention are employedduring an off-pump valve replacement procedure, it may be beneficial toprovide temporary valves and/or filters in the arterial system,downstream of the site of the native aortic valve. Thus, for example, inFIG. 1 there is shown a temporary valve 600 (not shown in the remainingfigures) which may be used to support cardiac function during andfollowing removal of the diseased cardiac valve. Temporary valve 600 isshown positioned in aorta 20. Alternatively, temporary valve 600 may bepositioned in the aortic arch or the descending aorta. In addition,temporary valve 600 may incorporate a filter therein to mitigate therisks of embolic complications. Alternatively, a separate filter may beemployed within the aorta and/or the branch arteries extendingtherefrom.

FIG. 2 shows first manipulation instrument 400 being used to manipulatetemporary prosthetic assembly 300 (and hence prosthetic valve 200) intoleft ventricle 25 through mitral valve 30. After temporary prostheticassembly 300 has passed into left ventricle 25, the first manipulationinstrument 400 will continue to traverse mitral valve 30; however, thereduced perpendicular cross-section of first manipulation instrument 400will cause only minimal disruption of the function of mitral valve 30.

FIG. 3 shows the insertion of a second manipulation instrument 500through the arterial system and into left ventricle 25. Secondmanipulation instrument 500 is shown being inserted through an incision35 on aorta 20. Alternatively, second manipulation instrument 500 couldbe inserted into a central or peripheral artery and than advanced intoleft ventricle 25. Aortic incision 35 is small relative to the atriotomy10 formed in left atrium 5.

Bleeding through incision 35 may be readily controlled through a varietyof means. These include, but are not limited to, employing a valved orun-valved arterial cannula, a purse-string suture placed around incision35 and then pulled tight about second manipulation instrument 500, aside-arm graft sewn to aorta 20 that may be constricted about a regionof second manipulation instrument 500, the use of a tight fit between aportion of second manipulation instrument 500 and aortic incision 35,etc.

Second manipulation instrument 500 is shown in FIG. 3 as being of thesame form and function of first manipulation instrument 400. Again,outer cannula 505 fits around inner grasper 510, and the relative motionbetween grasper 510 and cannula 505 can be used to deform gripper 515between open and closed positions. Alternatively, second manipulationinstrument 500 may have any of the variety of other forms and functionsdescribed above with respect to first manipulation instrument 400.Furthermore, second manipulation instrument 500 is preferably of asmaller dimension perpendicular to its long axis than first manipulationinstrument 400 so as to reduce the risks posed by arteriotomy 35.

FIG. 4 shows second manipulation instrument 500 being secured to thesecond manipulation mount 110 formed on prosthesis holding apparatus100. This is done while first manipulation instrument 400 is secured tofirst manipulation mount 105 formed on prosthesis holding apparatus 100,in order that temporary prosthetic assembly 300 will be under control atall times during the “hand-off” between first manipulation instrument400 and second manipulation instrument 500.

It should be appreciated that the orientation of second manipulationmount 110 is preferably such as to enable the long axis of secondmanipulation instrument 500 to be substantially perpendicular to theflow area of prosthetic valve 200. This arrangement is particularlyhelpful when guiding prosthetic valve 200 into its final position withinaorta 20 as shown hereafter in FIGS. 6 and 7.

The use of two separate manipulation instruments, and the method ofpassing valve prosthesis 200 from one to the other, avoids the complexmanipulations of valve prosthesis 200 that would be required to positionvalve 200 within aorta 20 using only a single manipulation instrumentintroduced through the left atrium. In this respect it should beappreciated that such a “single manipulation instrument” technique hasbeen found to be possible, however, and is best facilitated by using amanipulation instrument capable of bending or articulating at or nearthe site of its attachment to valve holding apparatus 100. In thisrespect it has been found that it can be particularly advantageous toprovide a manipulation instrument capable of bending or articulatingwithin about 4 cm or so of the point of attachment to valve holdingapparatus 100. It has also been found that it can be particularlyadvantageous for such an articulating instrument to be able to deflectits distal tip by an angle of between about 90 to 180 degrees from thelong axis of the first manipulation instrument 400 shown in FIG. 4.

The angular offset of first manipulation mount 105 and secondmanipulation mount 110 is preferably set to facilitate passage oftemporary prosthetic assembly 300 from left atrium 5 to aorta 20 usingtwo substantially straight manipulation instruments, e.g., firstmanipulation instrument 400 and second manipulation instrument 500. Thisangle is preferably approximately 45 degrees. However, this angle mayalso be varied so as to optimize passage of different valve designs orother prostheses using curved, straight or articulating manipulationinstruments from various access sites into the left atrium and arterialsystem. This angle may be fixed or variable on a given prosthesisholding apparatus 100.

Once second manipulation instrument 500 is safely secured to secondmanipulation mount 110, first manipulation instrument 400 may bereleased from first manipulation mount 105 and removed from leftventricle 5, as shown in FIG. 5. Alternatively, first manipulationinstrument 400 may remain secured to prosthesis holding apparatus 100 orprosthetic valve 200 by a flexible tether so as to facilitatere-attachment of first manipulation instrument 400 to valve holdingapparatus 100 if necessary.

FIG. 6 shows temporary prosthesis assembly 300 being positioned bysecond manipulation instrument 500 at a preferred fixation site. Thisfixation site is preferably upstream of or proximal to the coronaryarteries, although this position is not a restrictive requirement of thepresent invention.

FIG. 7 shows valve prosthesis 200 secured to the walls of aorta 30 andremoval of second manipulation instrument 500 and prosthesis holdingapparatus 100. In this respect it should be appreciated that prosthesisholding apparatus 100 is preferably wholly or partially flexible, orotherwise collapsible, so as to allow the prosthesis holding apparatus100 to be collapsed radially and then withdrawn through arteriotomy 35after prosthesis holding apparatus 100 has been released from prostheticvalve 200. Alternatively, prosthesis holding apparatus 100 may beremoved from the vascular system, either partially or entirely, throughatriotomy 10 by first manipulation instrument 400, by a tether leadingtherefrom, or a separate instrument. Of course, in the situation whereprosthesis holding apparatus 100 is to be removed via atriotomy 10, theprosthesis holding apparatus 100 should be appropriately mounted toprosthetic valve 200, i.e., prosthesis holding apparatus 100 should bepositioned on the atriotomy side of the valve.

In FIG. 7, valve prosthesis 200 is shown secured to aorta 30 using barbsor staples 700. Barbs or staples 700 may be a component of, and/ordeployed from, prosthesis holding apparatus 100, and/or valve prosthesis200, and/or a separate fixation device. Alternatively, barbs or staples700 may be deployed by a separate instrument inserted through the outersurface of aorta 30, from a remote site in the arterial system, throughatriotomy 10 or through some other incision into a cardiac chamber orgreat vessel.

Looking next at FIGS. 8-10, there is shown one preferred configurationfor prosthesis holding apparatus 100. More particularly, prosthesisholding apparatus 100 comprises a base 120 having a longitudinal opening123 (FIG. 9) therein for slidably receiving a rod 125 therethrough. Base120 also comprises a plurality of side slots 130. Each side slot 130 hasa strut 115 pivotally connected thereto. Slots 130 are constructed sothat each strut 115 can pivot freely between (i) the position shown inFIGS. 8 and 9, and (ii) the position shown in FIG. 10. A body 135 ismounted on rod 125. A plurality of wire fingers 140 are secured to body135. Wire fingers 140 extend through holes 145 formed in base 120 andextend around the cuff 205 of prosthetic valve 200. Second manipulationmount 110 is secured to the proximal end of rod 125. First manipulationmount 105 is secured to one of the struts 115. Alternatively, as notedabove, first manipulation mount 105 may be formed by a strut 115 itself,provided that first manipulation instrument 400 is appropriately adaptedto engage the strut 15 directly.

In use, prosthesis holding apparatus 100 is fit about valve prosthesis200 so that wire fingers 140 hold valve cuff 205 to struts 115.Prosthesis holding apparatus 100 is then engaged by first manipulationinstrument 400, using first manipulation mount 105, and moved into andthrough right atrium 5, through mitral valve 30 and into left ventricle25. Then second manipulation tool 500, comprising outer cannula 505 andinner grasper 510 having the deformable gripper 515, engages secondmanipulation mount 110. The distal tip 520 of outer cannula 505 isplaced against edge 150 of base 120 and gripper 515 is drawn proximallywithin outer cannula 505 until deformable gripper 515 engages shoulder525, whereupon prosthesis holding apparatus 100 (and hence prostheticvalve 200) will be mounted to second manipulation tool 500. Secondmanipulation tool 500 is then used to maneuver temporary prostheticassembly 300 into position, whereupon the valve's cuff 205 is secured tothe side wall of the aorta, e.g., with barbs, staples, suture, etc. Thenprosthesis holding apparatus 100 is detached from prosthetic valve 200by pulling inner grasper 510 proximally relative to outer cannula 505 sothat wire fingers 140 are pulled free from valve cuff 205 (FIG. 9),whereby to free prosthesis holding apparatus 100 from the prostheticvalve 200. Then second manipulation instrument 500 is withdrawn outaorta 20 and arteriotomy 35, with struts 115 folding inwardly (FIG. 10)so as to pass through the arteriotomy. Struts 115 can be adapted to foldinwardly through engagement with the walls of the arteriotomy 35 or,alternatively, additional means (such as springs, cams, etc.) can beprovided to fold struts 115 inwardly.

In practice, it has been found that it can sometimes be difficult tolocate second manipulation mount 110 with second manipulation instrument500 so as to “hand off” temporary prosthesis assembly 300 from firstmanipulation instrument 400 to second manipulation instrument 500. Thiscan be particularly true where the procedure is to be conducted“off-pump”, i.e., without stopping the heart. To this end, and lookingnow at FIG. 11, there is shown a guide 800 for guiding secondmanipulation instrument 500 relative to first manipulation instrument400 such that second manipulation instrument 500 will be aimed directlyat second manipulation mount 110 when first manipulation mount 105 issecured to first manipulation instrument 400. More particularly, guide800 comprises a first passageway 805 for slidably receiving firstmanipulation instrument 400, and a second passageway 810 for slidablyreceiving second manipulation instrument 500. Passageways 805 and 810are oriented so that second manipulation instrument 500 will be aimeddirectly at second manipulation mount 110 when temporary prosthesisassembly 300 is held by first manipulation instrument 400 engaging firstmanipulation mount 105.

In accordance with the present invention, it is also possible to enterthe left atrium other than through an exterior wall of the left atrium.Thus, for example, it is possible to introduce the prosthetic valvethrough an opening in an exterior wall of the right atrium, pass theprosthetic valve through an incision in the interatrial septum andacross to the left atrium, and then advance the prosthetic valve to itsimplantation site via the mitral valve and the left ventricle.

As noted above, the manipulation instrument(s) do not need to take theform of the installation instrument 400 or 500. It is also possible todeliver the prosthetic valve to its implant site using a guidewire and apusher tool riding on the guidewire.

Thus, for example, in an alternative preferred embodiment, a wire, acatheter, a tube or any other filament can be placed from the leftatrium, through the ventricle and into the arterial system, over (orthrough) which a prosthesis or device can be advanced (pushed orpulled). As an example, a catheter with a balloon can be placed throughan incision in the left atrial wall. The balloon can be inflated andthis catheter can then be “floated” along the flow of blood across themitral valve, into the left ventricle, and out into the arterial system.At that point the catheter can be grasped by an instrument placedthrough a small incision in the aorta or passed into the aorta by meansof a remote vessel such as the femoral artery. At this point, theprosthesis or device can be mounted onto the catheter and either bepushed (or pulled) over the catheter into position. This procedure canbe similarly performed by the use of a wire or other filament structure.Also, a tube could be employed, with the prosthesis or device beingadvanced within the tube.

Looking now at FIGS. 12-91, several preferred embodiments of the presentinvention are shown for removing a diseased valve without causing strokeor other ischemic events that might result from the liberation ofparticulate material. Valve resection may be necessary prior to valvereplacement of a diseased valve, such as a stenotic valve, which willnot open, or an insufficient valve, which will not close. In addition,the diseased valve may also be calcified or have a torn leaflet. In someof the preferred embodiments of the present invention, a crushing forceis delivered to the diseased valve so as to displace the diseased valveprior to implantation of a replacement valve. However, adequatedisplacement of the diseased valve prior to implantation of areplacement valve may not be possible due to calcification ordisplacement alone may not allow the desired placement of thereplacement valve. Several preferred embodiments of the presentinvention are configured to cut away and remove the diseased valve,rather than only crush it, so as to allow implantation of thereplacement valve at a desired location.

Referring now to FIG. 12, a valve punch 900 is shown having a firstframe member 905 and a second frame member 910 positioned relative toone another by an adjustable connector 915. In a preferred embodiment ofthe present invention, first frame member 905 holds a blade 920configured to form a closed perimeter and with its cutting surfacefacing toward second frame member 910. Second frame member 910 isconfigured with a corresponding cutting surface 925 facing toward theblade 920.

In use, punch 900 is positioned at a diseased valve (not shown) withadjustable connector 915 operated to space first frame member 905 andsecond frame member 910 apart from one another so as to receive at leasta portion of the diseased valve (not shown) therebetween. Next,adjustable connector 915 is operated so as to close first frame member905 and second frame member 910 toward one another. This action causesblade 920 to move past cutting surface 925 so as to sever the portion ofthe diseased valve (not shown) therebetween. Punch 900 may be removedwith the resected valve contained between first frame member 905 andsecond frame member 910. Punch 900 may be configured for either anapproach to the valve through the aorta, referred to as an aorticapproach, or an approach to the valve through the left ventricle of theheart, referred to as a left ventricle approach.

In a preferred embodiment of the present invention, and still referringto FIG. 12, punch 900 is configured to allow blood flow through firstframe member 905 and second member 910. Screen portions 930 may beprovided on first frame member 905 and second frame member 910 so as tocontain small pieces of the resected valve, which may otherwise becarried away.

Adjustable connector 915 of punch 900 is preferably configured with ahandle 935 for opening and closing first frame portion 905 and secondframe portion 910 relative to one another. A spring 940 is also providedto bias first frame portion 905 and second frame portion 910 closedrelative to one another. This configuration of punch 900 may be used inconnection with the left ventricle approach with handle 935 beingoperable with a two tube controller (not shown). Alternatively, theshaft of adjustable connector 915 may be threadably connected to eitherfirst frame member 905 or second frame member 910 so as to allowadjustable connector 915 to open or close punch 900 with a twistingmotion.

Looking now at FIGS. 13-17, an aortic approach punch 945 is shown forresecting diseased valve (not shown) using an aortic approach. Aorticapproach punch 945 includes a first frame member 950 and a second framemember 955, with the two frame members being selectively movable by anactuator 960 so as to engage one another. First frame member 950 andsecond frame member 955 contain cutting edges 965, 970, respectively.Cutting edges 965, 970 engage with one another as operated by actuator960 so as to sever and contain a portion of an aortic valve 975positioned therebetween.

In a preferred embodiment of the present invention, first frame member950 and second frame member 955 each contain a mesh filter 980. Eachmesh filter 980 allows blood flow through punch 945 and preventsportions of the resected valve larger than openings in mesh filter 980from passing through punch 945.

Looking now at FIG. 16, second frame member 955 is shown with a seat 985for holding a portion of the resected valve against a correspondingstructure of first frame member 950. Seat 985 is configured with voids990 so as to permit blood flow through punch 945 while simultaneouslyholding the resected portion.

Looking now at FIG. 17, the aortic approach punch 945 is shown withfirst frame member 950 and second frame member 955 each having cuttingteeth 995 in rotatable engagement with one another. Actuator 960 isconfigured to rotate and engage first frame member 950 and second framemember 955 relative to one another so as to cut portions of an aorticvalve therebetween using cutting teeth 995.

Referring now to FIG. 18-22, a power shaver guide 1000 is shown forresecting a heart valve with a power shaver 1005, such as a commerciallyavailable arthroscopic device. Power shaver guide 1000 includes anopening 1010 to receive power shaver 1005 therethrough. Power shaverguide 1000 is sized to fit within the aorta. Preferably, power shaverguide 1000 is sized large enough to prevent power shaver 1005 fromunintentionally cutting through a wall of the aorta but small enough tofit inside of the diseased valve. In addition, the diseased valve may becrushed prior to introduction of power shaver guide 1000 and powershaver 1005.

Looking now at FIGS. 18 and 19, a cutting window 1015 is provided inpower shaver guide 1000 to allow cutting therethrough and to shieldpower shaver 1005 from cutting through the wall of the aorta.

Looking now at FIGS. 20 and 21, power shaver guide 1000 is shown withopening 1010 configured to hold power shaver 1005 positionedtherethrough without requiring cutting window 1015 (see FIGS. 18 and19).

Looking now at FIG. 22, in another preferred embodiment of theinvention, power shaver guide 1000 is collapsible. Collapsible powershaver guide 1000 preferably comprises an inflatable balloon 1020.Inflatable balloon 1020 is shown in a collapsed state for insertion intothe aorta and in an inflated state for resection of the diseased valve.

Looking now at FIGS. 23-32, in another preferred embodiment of thepresent invention, there is shown an expandable resector 1025 havingthree expandable arms 1030, in which one expandable arm 1030 carries acutting device 1035. Cutting device 1035 includes a wire 1040, which iseither rotary driven or reciprocically driven, so as to cut portions ofa diseased valve. Wire 1040 is positioned within expandable arm 1030 tocreate a cutting window 1045. Cutting window 1045 may be formed eitherby recessing wire 1040 into expandable arm 1030 or by building up theportions of expandable arm 1030 surrounding cutting window 1045.

Wire 1040 may include a rough, abrasive surface for rotary driven orreciprocically driven cutting. Alternatively, wire 1040 may include anelectrocautery element for cutting. A power shaver may also be used inplace of wire 1040. The rough or abrasive embodiment of wire 1040 mayinclude recesses formed in the wire 1040 or an abrasive metal dustcoating added to it.

Looking now at FIGS. 33-37, in another preferred embodiment of thepresent invention, there is shown a spiked resector 1050. Spikedresector 1050 includes at least two spikes 1055 to hold valve leafletsin place as frame members 1065, 1070 are advanced toward one another.Spiked resector 1050 also includes a spike receiving portion 1060 toallow frame members 1065, 1070 to closely approach one another in orderthat a cutting mechanism 1075 (FIG. 37) cuts through the valve leaflets.In addition, one of the frame members 1065, 1070 may be mounted to ascrew-driven assembly 1080 so as to axially rotate the mounted framemember to aid in cutting.

Referring now to FIGS. 38-49, in another preferred embodiment of thepresent invention, there is shown an expandable blade resector 1085 forresection of a heart valve using a catheter 1090. Expandable bladeresector 1085 includes a set of blades 1095 and a hinged portion 1100.Blades 1095 and hinged portion 1100 are selectively positionable throughcatheter 1090. In a preferred embodiment of the present invention,expandable blade resector 1085 includes a filter mesh portion 1105 (FIG.44) at a distal end thereof covering hinge 1095. Filter mesh portion1105 acts to capture portions of the resected valve. Blades 1095 mayalso be serrated to aid in cutting through a valve.

Looking now at FIGS. 50-57, in another preferred embodiment of thepresent invention, there is shown an expandable cylinder resector 1110for resection of a heart valve using a catheter 1115. Expandablecylinder resector 1110 includes an inner rod 1120 attached to catheter1115, an outer shell 1125 attached to inner rod 1120 at a first portion1130 and in surrounding relation to inner rod 1120, and a spring 1135being attached to outer shell 1125 at a second portion 1138 andcontained by outer shell 1125. Expandable cylinder resector 1110 isoperated by placing the outer shell 1125 within a portion of a heartvalve and then turning inner rod 1120 to allow spring 1135 to expand thediameter of outer shell 1125 relative to inner rod 1120. In thisconfiguration, expandable cylinder resector 1110 may be used to crushportions of a valve and/or as a centering guide in combination withanother resecting tool shown mounted at 1140 (FIG. 55).

Looking now at FIGS. 53 and 54, inner rod 1120 is preferably adjustableto selectively open and close together two portions 1145, 1150 of outershell 1125. These portions 1145, 1150 may be placed in an open positionadjacent to an aortic valve and then actuated by inner rod 1120 to aclosed position so as to cut through the aortic valve.

Referring now to FIGS. 58-60, in another preferred embodiment of thepresent invention, there is shown a power auger cutter 1155 for cuttingand removing portions of a heart valve. Power auger cutter 1155 includesa tubular body 1160 containing an auger blade 1165. An opening 1170 isformed in tubular body 1160 to allow portions of a heart valve into theinterior of power auger cutter 1155. Power auger cutter 1155 isconfigured to cut portions of the heart valve extending into opening1170 by carrying the portions with auger blade 1165 deeper into tubularbody 1160 until auger blade 1165 contacts tubular body 1160 at ajunction 1180. After the severed portions of the heart valve passjunction 1180, auger blade 1165 continues to carry these portionsthrough tubular body 1160 and out of the aorta.

Looking now at FIGS. 58 and 59, power auger cutter 1155 is provided witha set of guides 1185. Guides 1185 are positioned around at least aportion of opening 1170, which acts to shield against cutting the wallof the aorta. Preferably, the width of power auger cutter 1155 is about0.20% of the aorta.

Looking at FIG. 60, power auger cutter 1155, configured without a set ofguides, is preferably used with a delivery system. The delivery systemeither provides a shield against cutting the wall of the aorta orpositions power auger cutter 1155. One such system is the expandableresector with three arms.

Referring now to FIGS. 61-63, in a preferred embodiment of the presentinvention, there is shown an offset cutter 1190. Offset cutter has aninner rod 1195, an outer shell 1200, and a cutting blade 1205 positionedat the end of outer shell 1200. The diameter of outer shell 1200 iscontrolled by increasing or decreasing its length extending out of innerrod 1195. The large diameter of outer shell 1200 acts as a guide toshield against cutting the wall of the aorta with cutting blade 1205 asit cuts away portions of a heart valve.

Referring now to FIGS. 64-70, in a preferred embodiment of the presentinvention, there is shown a trisector 1210 having three blades 1215 forresecting a heart valve. In a preferred embodiment of the presentinvention, barbs 1220 are provided at a center portion of the trisectorto spear and hold the leaflets of the heart valve while blades 1215 spinto cut through the heart valve. Blades 1215 may be configured to cut ata forward portion of trisector 1210, in which case trisector 1210 actsas plunging cutter. Alternatively, blades 1215 may be configured to cutat a side portion of the trisector 1210, in which trisector 1210 acts asa side cutter. For very hard calcification of a heart valve, it ispreferred that trisector 1210 be configured as a plunging cutter to cutin a forward direction.

In an alternative preferred embodiment of the present invention,trisector 1210 is provided with a filtering mechanism 1220 (FIG. 68) tocontain cut away portions of the valve for removal from the patient'sbody.

Referring now to FIGS. 71-76, in a preferred embodiment of the presentinvention, there is shown a valve entrapment cutter 1225. Valveentrapment cutter 1225 includes a chamber 1230 with a retractable barb1235 and a set of blades 1240 surrounding an end of chamber 1230. Blades1240 may be configured to rotate around barb 1235 so as to cut through aportion of a valve pierced by barb 1235 as the portion enters chamber1230. Alternatively, chamber 1230 may be configured to rotate aroundbarb 1235 as the portion enters chamber 1230.

Referring now to FIGS. 77-79, in a preferred embodiment of the presentinvention, there is shown a gripper cutter 1240 for the resecting of aportion of a heart valve. Gripper cutter 1240 includes a pair ofgraspers 1245 contained in a body 1250 with a cutting element 1255positioned therebetween. Graspers 124 are extended distally from thedistal end of body 1250 so as to contact a portion 1260 of a heartvalve. Graspers 1245 are closed together through actuation of eithergraspers 1245 or body 1250. Graspers 1245 are then retracted with heartvalve portion 1260 into body 1250. Cutting element 1255 closes togetherafter graspers 1245 are retracted to a given point proximal to the endof cutting element 1255. This action causes heart valve portion 1260 tobe cut away from the remaining portion of the heart valve and to becontained within body 1250.

Referring now to FIGS. 80-90, in a preferred embodiment of the presentinvention there is shown valve cutter and resector 1265 for use in aleft ventricle approach. Valve cutter and resector 1265 includes a firsthandle 1270 for connection to a pass-off tool 1275 located in the leftventricle of the heart, a second handle 1280 for connection to acontroller tool 1285 located in the aorta, a body portion 1290 betweenfirst handle 1270 and second handle 1280, a cutting blade 1295 axiallyrotatable on the inside surface of body portion 1290, and a set ofretaining arms 1300 (FIG. 86) selectively expandable from second handle1280. Valve cutter and resector 1265 is operable to resect a portion1305 of an aortic valve 1310 by advancing through the left ventricle ofthe heart to aortic valve 1310 by means of pass-off tool 1275. Next,controller tool 1285 is advanced through the aorta, passes through theopening of aortic valve 1310 and is received by second handle 1280.First handle 1270 is then disengaged from pass-off tool 1275. Controllertool 1285 draws body portion 1290 distally with cutting blade 1295spinning to cut through aortic valve 1310. Retaining arms 1300 expandfrom a folded configuration within second handle 1280 and hold resectedportion 1305 within body portion 1290. First handle 1270 is repositionedand re-engaged to pass-off tool 1275 for removal through the leftventricle of the heart, with controller tool 1285 being disengaged fromsecond handle 1280.

Referring now to FIG. 91, in a preferred embodiment of the presentinvention, there is shown a resection tool 1315 having a protectiveguide 1320A-1320D to prevent cutting of the aortic wall through anopening 1325. In a preferred embodiment of the present invention,protective guide 1320A is a rigid structure in a surroundingconfiguration to opening 1325. This embodiment is illustrated by the“double bridge” design. In another preferred embodiment of the presentinvention, protective guide 1320B-1320D is a flexible structure adjacentto opening 1325. This embodiment is illustrated by the “inchworm”,“cantilever”, and “window slide” designs, in which a maximum deformationof the flexible structure is shown in phantom.

Looking next at FIGS. 92-101, there is shown a modified form of valvecutter and resector 1265. Again, this particular embodiment ofdebridement tool was designed with left atrial insertion andintra-cardiac hand-off in mind. A basic idea of this embodiment is theuse of a thin-walled cylinder or body portion 1290 size-specific for thepatient's anatomy. Here the tolerances are fairly small. The patient'sleft ventricular outflow tract and aortic valve annulus are carefullymeasured by transesophageal echo. An appropriately sized debridementtool 1265 (with an appropriately sized thin-wall cylinder 1290) is thenselected. Within the thin-walled cylinder 1290 is a cylindrical razor orcutting blade 1295 with a serrated edge. This razor can be rotatedmanually by means of a catheter or controller tool 1285 attached duringhand-off. The razor 1295 is completely contained within the thin-walledcylinder 1290 until actuated. The back of the cylinder is attached to awire cage 1330 that streamlines the profile to facilitate insertion andremoval of the debridement tool across the mitral valve, and supports acup of filter material 1335 (shown schematically in FIG. 92 only) tocapture the valve and valve debris liberated at the time of debridement.Coaxial to, and extending a few centimeters forward of, the cylinder isthe transvalvular snout, or second handle, 1280. This consists of athin-walled tube with multiple side fenestrations that is forced acrossthe stenotic valve. The multiple fenestrations allow the continuedpassage of blood across the orifice, without exacerbating the degree ofstenosis or the outflow tract gradient.

The debridement tool is passed across the mitral valve on the beatingheart. A catheter or controller tool 1285 based across the stenoticaortic valve (transvalvular catheter) is advanced into the leftventricular chamber, to effect an intra cardiac hand-off, as describedpreviously. In one possible construction, the hand-off catheter 1285 ispassed percutaneously, perhaps down the central lumen of a valve/filterassembly, also passed percutaneously.

Ideally, the snout 1280 of the debridement tool and the tip of thetransvalvular catheter 1285 are both fitted with rare earth magnets orother appropriate structures so as to facilitate rapid reproduciblealignment. Once aligned, the transvalvular catheter 1285 is actuated toachieve a mechanical coupling to allow the debridement tool to be pulledforcibly into position. The tool 1275 which was initially used to passthe debridement tool across the mitral valve is then released andremoved after mechanical coupling is accomplished, but before pullingthe debridement tool into position across the stenotic valve.

Attached to the aforementioned snout 1280 is an umbrella 1300 comprisedof rays (or struts of nitinol or other superelastic material) or othersatisfactory material supporting a disk of filter material 1340 similarto that attached to the back of the debridement tool. The umbrella 1300is designed so that it can be pulled across the stenotic valve in aclosed configuration, from the ventricular side of the valve to theaortic side of the valve, and subsequently opened. The umbrella strutsform a skeleton with a radius equal to that of the thin-walled cylinder1290, and slightly greater than the cylindrical razor 1295. The disk offilter material has a radius that is somewhat greater than that of thethin-walled cylinder 1290. The umbrella struts may be attached to a ringthat slides longitudinally with respect to the snout. The transvalvularcatheter, when actuated, causes both delivery of the umbrella to theaortic side of the valve as well as a configuration change from closedto open. The result is that the stenotic valve is impaled on the snoutand wedged between the thin-walled cylinder on the ventricular side andthe open umbrella on the aortic side.

In one embodiment, the umbrella 1300 is inverted. That is to say, whenit is pulled across the stenotic valve, the apex of the umbrella is thefirst to pass, and the outer circumference of the umbrella tines andfilter disk is last to pass. In this construction, the device ispreferably spring-loaded so that when the tips of the tines clear thevalve orifice and tension is released, the umbrella forms as a result ofits own recoil against the aortic surface of the valve.

The geometry and construction of the debridement tool is such that itwill orient coaxially with respect to the left ventricular outflow tractand the valve orifice. Once the umbrella 1300 is deployed, the positionis carefully inspected by echo and/or fluoroscopy. When correctlydeployed, only a small gap exists between the disk and the thin-walledcylinder. It is therefore impossible to position and deploy the devicewith anything other than valvular tissue within this narrow gap. Only ifthe debridement tool was deployed at a significant angle, or wasmarkedly undersized, could aortic or left ventricular tissue becomepinched in this gap. Once it is confirmed that the debridement tool'sposition is correct, and the umbrella 1300 is deployed, the cylindricalrazor 1295 is manually advanced and rotated, again under echo and/orfluoroscopic guidance, while maintaining tactile feedback by way of arotating central element of the transvalvular catheter. It is notimperative that the valve be debrided in its entirety; rather, that ahole result that has edges suitable for the fixation mechanism, and thatis large enough to allow fixation of the prosthesis, and that willrelieve the outflow tract gradient. As the fixation mechanism and theorifice of the prosthesis may not be co-planer in this application, thedemands on debridement and orifice size may be considerably less thanwith a conventional prosthetic valve implantation.

As soon as the cylindrical serrated razor 1295 cuts through the last ofthe valvular tissue, there will be no tissue remaining to prevent thespring-loaded umbrella 1300 from retracting toward the thin-walledcylinder 1290, in effect snapping a lid on the cylinder with the valveremnants inside. Inasmuch as the umbrella 1300 and the cage 1330 at theback of the thin-walled cylinder are covered with filter material, thevalve tissue cannot escape. Because the filter material is fairlytransparent to blood, resistance to flow and cardiac emptying should notbe significantly impacted by its presence in the left ventricularoutflow tract. A single-use serrated cylindrical razor 1295, with teethof an appropriately small size, when used in a proper fashion (multiplesmall amplitude rotations while applying minimal force) will be able tocut a smooth round hole out of even the most calcified and thickenedvalve.

Once the umbrella is seen (by echo and/or fluoro) to have snapped downon the cylinder, the inference is made that the valve has beencompletely excised. Valvular competence at this point is providedentirely by the down-stream valve, an embodiment of which is describedas the valved arch filter (see U.S. Provisional Patent Application Ser.No. 60/425,877, filed Nov. 13, 2002 by William E. Cohn for CARDIAC VALVEPROCEDURE METHODS AND DEVICES, which patent application is herebyincorporated herein by reference). Any particulate material that escapesthe debridement tool is prevented from embolizing by this down-streamfilter.

The closed debridement tool, with the valve remnants inside, is thenpassed back across the mitral valve and removed through the left atrialblood-lock.

It should also be appreciated that a valve debridement tool may alsocomprise a laser, an ultrasonic device, a rotary drill bit, an auger, orany other mechanism that appropriately disrupts tissue.

Furthermore, the valve debridement tool can be passed down the aorta,through the valve and across to the ventricular side for deployment andretrograde cutting.

Preferably the valve debridement tool is formed so as to be selectivelycollapsible, whereby it may be advanced to the surgical site through acatheter, e.g., by a catheter introduced through a peripheral artery.

In the foregoing description, the debridement tool of FIGS. 92-101 wasdiscussed in the context of a left atrial insertion and an intra-cardiachandoff, e.g., the debridement tool is introduced into the left atriumby passing it through the side wall of the left atrium; the debridementtool is passed across the mitral valve and into the left ventricle; atransvalvular catheter is passed down the aorta and across the aorticvalve; and the transvalvular catheter engages the debridement tool,establishes the requisite mechanical coupling therewith and carries thedebridement tool up to the aortic valve, where the desired debridementis effected.

In another form of the invention, the left atrial insertion andintra-cardiac handoff may be effected in another manner.

More particularly, and looking next at FIG. 102, the debridement tool1400 is mounted on a debridement catheter 1405 and introduced into thepatient's femoral vein (not shown), advanced up the inferior vena cava(not shown), passed into the right atrium 1415, then moved through theatrial septum (not shown) into the left atrium 1420, and then passedthrough the mitral valve 1425 into the left ventricle 1430. For purposesof convenient description, this approach can be considered to be an“antegrade” approach, since it is in the same direction as blood flow.

Looking next at FIG. 103, the transvalvular catheter 1435 is introducedinto the patient's femoral artery (not shown), moved up the aorta 1440,advanced up over the aortic arch 1445, and then brought down through theaortic valve 1450 and into the left ventricle 1430. For purposes ofconvenient description, this approach can be considered to be a“retrograde” approach, since it is in a direction opposite to bloodflow.

At this point, and looking next at FIG. 104, the transvalvular catheter1435 engages the debridement tool 1400 and establishes the requisitemechanical coupling.

Next, and looking now at FIG. 105, the transvalvular catheter 1435 isused to pull the debridement tool 1400 up to the aortic valve 1435,where the debridement is effected. Preferably the debridement catheter1450, which is also still connected to the debridement tool 1400, isused to assist transvalvular catheter 1435 during such advancement andthe debridement action.

Thereafter, once debridement is complete, the debridement tool 1400 canbe disconnected from the transvalvular catheter 1435, and then thedebridement catheter 1405 (with the debridement tool 1400 attached) andthe transvalvular catheter 1435 withdrawn from the body.

In order to facilitate the intra-cardiac handoff, the debridement tool1400 and the transvalvular catheter 1435 may contain magnets 1455, 1460to assist alignment of the devices. Neodymium-iron-boron, or other rareearth magnets, can provide adequate field strength even in the smallsizes desired for intraluminal delivery techniques.

Significantly, since the debridement tool 1400 is simultaneously engagedby both the debridement catheter 1405 and the transvalvular catheter1435 during the actual debridement procedure, the debridement tool 1400is maintained under superior control throughout the debridementprocedure. In particular, since one end of the debridement tool 1400 isconnected to the transvalvular catheter 1435 and the other end of thedebridement tool 1400 is connected to the debridement catheter 1435, thesurgeon can use a combination of push-pull actions on the two catheters1405, 1435 so as to ensure optimum maneuvering of the debridement toolabout the debridement site.

In connection with the foregoing procedure, and as noted above, wherethe defective native aortic valve 1450 is to be debrided and replaced bya prosthetic valve (not shown), it is important to (1) position atemporary valve (not shown) in the aorta 1440 to provide the requisitevalve function, and (2) position a filter (not shown) in the aorta 1400to entrap particles created by the debridement procedure. Preferablythese two functions are provided by a single, combined valve-and-filterdevice (not shown). In one preferred form of the invention, this single,combined valve and filter device permits the transvalvular catheter 1435to pass therethrough. In one particularly preferred form of theinvention, this single, combined valve-and-filter device (not shown)comprises the valved arch filter (not shown) described in U.S.Provisional Patent Application Ser. No. 60/425,877, filed Nov. 13, 2002by William E. Cohn for CARDIAC VALVE PROCEDURE METHODS AND DEVICES,which patent application is hereby incorporated herein by reference,with the transvalvular catheter 1435 passing down the central lumen ofthe valved arched filter.

In the foregoing description, left atrial insertion and intra-cardiachand-off has been discussed in the context of maneuvering a debridementtool 1400 up to, and about, the seat 1465 of the aortic valve 1450.However, the same approach can also be used to advance and manipulateother elements (not shown) within the heart 1470 as well, e.g., aprosthetic aortic valve (not shown) could be installed at the aorticseat 1465 using a similar technique. As referred to herein, theprosthetic heart valves used in accordance with the various devices andmethods of heart valve delivery may include a wide variety of differentconfigurations, such as a prosthetic heart valve having tissue leafletsor a synthetic heart valve having polymeric, metallic, ortissue-engineered leaflets, and can be specifically configured forreplacing any heart valve. That is, while much of the description hereinrefers to replacement of aortic valves, the prosthetic heart valves ofthe invention can also generally be used for replacement of nativemitral, pulmonic, or tricuspid valves, for use as a venous valve, or toreplace a failed bioprosthesis, such as in the area of an aortic valveor mitral valve, for example.

1. A prosthetic heart valve in combination with a delivery assembly, thedelivery assembly including a first elongate component that is movablydisposed to a second elongate component, the delivery assembly having atemporary valve location relative to the delivery assembly to which theprosthetic heart valve can be releasably mounted in position and aspaced implantation location relative to the delivery assembly to whichthe prosthetic heart valve can also be releasably mounted in position,the prosthetic heart valve and delivery assembly combination beingconfigurable with movement of the first elongate component relative tothe second elongate component from a delivery state with the prostheticheart valve mounted in the temporary location on the delivery assemblyto an implantation state with the prosthetic heart valve released fromcontact with the delivery assembly at the temporary location andrelocated to the implantation location so that the prosthetic heartvalve can subsequently be deployed from the implantation location. 2.The combination of claim 1, wherein the prosthetic heart valve is areplacement aortic valve.
 3. The combination of claim 1, furthercomprising a holder connected with the prosthetic heart valve, and theholder can be releasably connected between the first and second elongatecomponents.